OnchocerciasisPhase 1NCT03962062

A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years

A Phase 1 study testing Moxidectin in people with Onchocerciasis, run by Medicines Development for Global Health at 1 site in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 to 17 years
Conditions the study is for: Onchocerciasis
What is being tested?: Moxidectin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteGhana
Study dates: 29 Mar 2021to 28 Sep 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Aged 4 to 17 years, inclusive:
Cohort I: 12 to 17 years;
Cohort II: 8 to 11 years;
Cohort III: 4 to 7 years;
Live in a region designated by the World Health Organization (WHO) as endemic for O. volvulus infection (World Health Organization, 2019). Specifically, participants will be recruited from the Kpassa sub-district of the Nkwanta North district.The specific communities will include Wii, Jagri-Do, and Azua where mass drug administration with ivermectin for onchocerciasis commenced in October 2017;
Willing and able to remain at the study clinic from Screening up to Day 7;
Provision of parental or guardian written informed consent and assent / lack of expression of 'deliberate objection' (as appropriate for age);
Females of childbearing potential must commit to using a reliable method of contraception as per local family planning guidelines from Baseline (pre-treatment on Day 0) until approximately 6 months after treatment with study drug.

Who cannot join

History of serious medical or psychiatric condition which, in the opinion of the investigator, would put the subject at increased risk by participating in the study or jeopardize study outcomes;
Known or suspected concurrent clinically significant renal, cardiac, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunological disorders or malignancy, congenital heart disease, chronic lung disease;
Has received an investigational product within 28 days or 5 half-lives of Baseline, whichever is longer;
Has received ivermectin or any other anti-helminthic treatments within 28 days of Baseline;
Has received a vaccination within 7 days of Baseline;
Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin;

Show all 25Show fewer

Poor venous access;
Unable to swallow tablets (flat oval, 8.0 millimeters (mm) x 4.5 mm x 3.0 mm);
Weight:
Cohort I (12 to 17 years): < 30 kg;
Cohort II (8 to 11 years): < 18 kg;
Cohort III (4 to 7 years): < 12 kg;
Clinically relevant laboratory abnormalities at Screening, including:
Hemoglobin < 9.5 grams per deciliter (g/dL);
Neutrophil (granulocyte) count < 1.5 x 109/L;
Platelet count < 110 x 109/L;
Alanine aminotransferase (ALT) > 1.5 times the upper limit of normal range (ULN);
Total bilirubin > 1.5 times ULN;
Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) positive;
Known or suspected malaria or other ongoing viral, bacterial, or plasmodium infection at Screening and/or Baseline;
Loa loa co-infection;
Unwilling, unlikely or unable to comply with all protocol specified assessments;
For females of child bearing potential, pregnant or breastfeeding, or planning to become pregnant;
Previous enrolment in this study;
Is a sibling of another child already enrolled in this study.

Trial locations and contacts

1 site in 1 country.

Ghana1 site

University of Health and Allied Services School of Public Health
Hohoe, Volta Region

Other trials in Ghana

About this study

Official title: An Open-label Study of the Pharmacokinetics and Safety of a Single Dose of Moxidectin Per Oral in Subjects Aged 4 to 17 Years With (or at Risk of) Onchocerciasis to Identify an Optimal Dose for Treatment of Children 4 to 11 Years

The primary purpose of this study is to determine a dose of moxidectin for children 4 to 11 years that is equivalent to an 8 mg dose administered for treatment of onchocerciasis in people 12 years and over. The secondary purpose is to evaluate the safety and pharmacokinetics of a single dose of moxidectin in children and adolescents aged 4 to 17 years.

Conditions: Onchocerciasis
Being tested: Moxidectin
Medical subject headings: Onchocerciasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MoxidectinDrug
2 mg tablets

Study groups in NCT03962062
Study group	Role	What they receive
Cohort 1: 12-17 years	Experimental	Moxidectin 8mg per oral, single dose Receives: Drug: Moxidectin
Cohort 2: 8-11 years	Experimental	Moxidectin 8mg (or lower dose) per oral, single dose Receives: Drug: Moxidectin
Cohort 3: 4-7 years	Experimental	Moxidectin single dose, determined by population pharmacokinetic modelling including data from Cohorts 1 and 2 Receives: Drug: Moxidectin

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration Versus Time Curve of Moxidectin.
Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.
Measured: Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72 and Days 7, 14 and 28.

Secondary outcomes (3)

Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin
Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.
Measured: Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72, Days 7, 14 and 28 and Week 12.
Maximum Observed Plasma Concentrations (Cmax) of Moxidectin
Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.
Measured: Pre-dose (Screening) and post-dose at Hours 1, 2, 4 and 8.
Incidence and Severity of Adverse Events.
Incidence and severity of adverse events, assessed by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric Adverse Events, Version 2.1.
Measured: Day 0 to Week 24 inclusive.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 202128 Sep 2022

First posted23 May 2019
Study start29 Mar 2021
Primary completion30 May 2022
Study completion28 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OnchocerciasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Prospective, age-stratified, adaptive, open-label, single-dose study with 3, age-defined cohorts. Cohort 1 (12 to 17 years, n = 9) and Cohort 2 (8 to 11 years, n = 9) will receive moxidectin 8 mg. Cohort 3 (4 to 7 years, n = 9) will receive moxidectin at a dose to be determined from safety and pharmacokinetic data analyses of Cohorts 1 and 2. If the starting dose for Cohorts 2 and 3 results in at least 3 subjects with moxidectin exposures above the target range, a revised dose will be determined in decrements of 2 mg and the Cohort(s) will be repeated with at least 9 new subjects. For Cohort 3, if the starting dose results in at least 3 subjects with moxidectin exposures below the target range, a revised dose will be determined in increments of 2 mg to a maximum dose of 8 mg.Therefore, it is expected that the study will enroll 27 subjects. However, if additional cohorts are required to meet pharmacokinetic outcomes, up to a maximum of 63 subjects may be enrolled.
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03962062
Sponsor's protocol ID: MDGH-MOX-1006
Status last verified: Dec 2024
First submitted: 22 May 2019
Last updated: 5 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Deidentified individual participant data in the form of data listings and SDTM and ADaM datasets may be available for sharing on application to the Sponsor.

Publications

Opoku NO, Doe F, Agbogah ME, Laryea R, Gordor SK, Donkor BS, Anyomitse E, Kugali D, van Zutphen-van Geffen M, Navarro DJ, Rayner CR, Patel K, Kuesel AC, Lowe M, Kinrade S. Identification of a moxidectin dose for 4- to 11-year-old children to support registration and potential use for onchocerciasis elimination: results of an open-label pharmacokinetic and safety study. Parasit Vectors. 2025 Jul 24;18(1):295. doi: 10.1186/s13071-025-06891-z.
PubMed 40707999

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study of the Pharmacokinetics and Safety of a Single Dose of Moxidectin Per Oral in Subjects Aged 4 to 17 Years With (or at Risk of) Onchocerciasis to Identify an Optimal Dose for Treatment of Children 4 to 11 Years
ClinicalTrials.gov ID: NCT03962062
Acronym / sponsor ID: MDGH-MOX-1006
Conditions: Onchocerciasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Medicines Development for Global HealthUniversity, hospital or other
Study start: 29 Mar 2021 (actual)
Primary completion: 30 May 2022 (actual)
Study completion: 28 Sep 2022 (actual)
First posted: 23 May 2019 (actual)
Results: Posted 22 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: Prospective, age-stratified, adaptive, open-label, single-dose study with 3, age-defined cohorts. Cohort 1 (12 to 17 years, n = 9) and Cohort 2 (8 to 11 years, n = 9) will receive moxidectin 8 mg. Cohort 3 (4 to 7 years, n = 9) will receive moxidectin at a dose to be determined from safety and pharmacokinetic data analyses of Cohorts 1 and 2. If the starting dose for Cohorts 2 and 3 results in at least 3 subjects with moxidectin exposures above the target range, a revised dose will be determined in decrements of 2 mg and the Cohort(s) will be repeated with at least 9 new subjects. For Cohort 3, if the starting dose results in at least 3 subjects with moxidectin exposures below the target range, a revised dose will be determined in increments of 2 mg to a maximum dose of 8 mg.Therefore, it is expected that the study will enroll 27 subjects. However, if additional cohorts are required to meet pharmacokinetic outcomes, up to a maximum of 63 subjects may be enrolled.

Arm	Type	Receives
Cohort 1: 12-17 years	Experimental	Drug: MoxidectinMoxidectin 8mg per oral, single dose
Cohort 2: 8-11 years	Experimental	Drug: MoxidectinMoxidectin 8mg (or lower dose) per oral, single dose
Cohort 3: 4-7 years	Experimental	Drug: MoxidectinMoxidectin single dose, determined by population pharmacokinetic modelling including data from Cohorts 1 and 2

Who may qualify

Ages: 4 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Aged 4 to 17 years, inclusive:
Live in a region designated by the World Health Organization (WHO) as endemic for O. volvulus infection (World Health Organization, 2019). Specifically, participants will be recruited from the Kpassa sub-district of the Nkwanta North district.The specific communities will include Wii, Jagri-Do, and Azua where mass drug administration with ivermectin for onchocerciasis commenced in October 2017;
Willing and able to remain at the study clinic from Screening up to Day 7;
Provision of parental or guardian written informed consent and assent / lack of expression of 'deliberate objection' (as appropriate for age);
Females of childbearing potential must commit to using a reliable method of contraception as per local family planning guidelines from Baseline (pre-treatment on Day 0) until approximately 6 months after treatment with study drug.

Key exclusion criteria (25 listed)

History of serious medical or psychiatric condition which, in the opinion of the investigator, would put the subject at increased risk by participating in the study or jeopardize study outcomes;
Known or suspected concurrent clinically significant renal, cardiac, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunological disorders or malignancy, congenital heart disease, chronic lung disease;
Has received an investigational product within 28 days or 5 half-lives of Baseline, whichever is longer;
Has received ivermectin or any other anti-helminthic treatments within 28 days of Baseline;
Has received a vaccination within 7 days of Baseline;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Moxidectin2 mg tablets	Drug	Cohort 1: 12-17 years, Cohort 2: 8-11 years, Cohort 3: 4-7 years

Primary outcome

Area Under the Plasma Concentration Versus Time Curve of Moxidectin.
Time frame: Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72 and Days 7, 14 and 28.
Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.

3 secondary outcomes

Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin
Time frame: Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72, Days 7, 14 and 28 and Week 12.
Maximum Observed Plasma Concentrations (Cmax) of Moxidectin
Time frame: Pre-dose (Screening) and post-dose at Hours 1, 2, 4 and 8.
Incidence and Severity of Adverse Events.
Time frame: Day 0 to Week 24 inclusive.

Results and safety

Results posted to the registry on 22 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
12 to 17 Years MOX 8 mg	9	9
8 to 11 Years MOX 8 mg	9	9
8 to 11 Years MOX 6 mg	9	9
4 to 7 Years MOX 4 mg	9	9

Primary outcome: Area Under the Plasma Concentration Versus Time Curve of Moxidectin.

Time frame: Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72 and Days 7, 14 and 28.. Geometric mean (Geometric Coefficient of Variation). Unit: (hr*ng/mL)/mg

Measure	12 to 17 Years MOX 8 mg n = 9	8 to 11 Years MOX 6 mg n = 9	8 to 11 Years MOX 8 mg n = 9	4 to 7 Years MOX 4 mg n = 9
Value	2680 (24.7)	2230 (52.3)	3310 (23.0)	1880 (26.5)

Population analysed: The Pharmacokinetic Analysis Set included all participants who received moxidectin and provided a minimum number of plasma samples for the determination of Pharmacokinetic (PK) parameters, defined as one (1) sample taken at each of hours 4, 24 and 72, plus one (1) sample taken at either Day 14 or Day 28. Subjects were analyzed according to the dose received.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 0 to 24 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
12 to 17 Years MOX 8 mg	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
8 to 11 Years MOX 6 mg	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9
8 to 11 Years MOX 8 mg	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
4 to 7 Years MOX 4 mg	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9
Overall	0 of 36 (0%)	24 of 36 (66.7%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 40707999Opoku NO, Doe F, Agbogah ME, Laryea R, Gordor SK, Donkor BS, Anyomitse E, Kugali D, van Zutphen-van Geffen M, Navarro DJ, Rayner CR, Patel K, Kuesel AC, Lowe M, Kinrade S. Identification of a moxidectin dose for 4- to 11-year-old children to support registration and potential use for onchocerciasis elimination: results of an open-label pharmacokinetic and safety study. Parasit Vectors. 2025 Jul 24;18(1):295. doi: 10.1186/s13071-025-06891-z.
Identification of a moxidectin dose for 4- to 11-year-old children to support registration and potential use for onchocerciasis elimination: results of an open-label pharmacokinetic and safety study.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Deidentified individual participant data in the form of data listings and SDTM and ADaM datasets may be available for sharing on application to the Sponsor.

Related trials for Onchocerciasis

Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
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Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicholas O Opoku, MD principal investigator

University of Health and Allied Sciences School of Public Health, Hohoe, Ghana

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Moxidectin in people with Onchocerciasis, run by Medicines Development for Global Health at 1 site in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration Versus Time Curve of Moxidectin. (time frame: Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72 and Days 7, 14 and 28.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03962062, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.